Twins MR Imaging Study

January 24, 2024 updated by: King's College London

Characterising Biomarkers of Disease and Ageing in Twins Using Magnetic Resonance Imaging

This study aims to create a comprehensive Magnetic Resonance Imaging data resource in twins aged 18 years and older. The data will be used alone or in conjunction with existing data to explore organ-specific ageing and twin-pair differences related to ageing and disease.

Study Overview

Status

Enrolling by invitation

Conditions

Detailed Description

BACKGROUND Diverse interactions between environmental, genetic, and epigenetic factors shape individual paths of ageing and disease. In young adulthood, twins are highly similar in most organ structures, but their similarity decreases over time as they are progressively exposed to different environments. Twin studies provide an ideal way to investigate how the body ages and how age-related diseases (such as Alzheimer's disease, heart failure, fatty liver disease, and cancer) develop. Magnetic Resonance Imaging (MRI) is a type of scan that produces detailed images of the inside of the body. MRI enables non-invasive and safe visualisation of age and disease-related changes in the body, often long before clinical symptoms are perceived. MRI-derived biological features/biomarkers can be used to understand the influence of environmental exposures on ageing and disease.

PARTICIPANTS 2500 adult (age 18 and older) volunteers of TwinsUK, the UK's largest adult twin Biobank and the most clinically detailed globally, will be invited to participate. Interested individuals will complete screening to confirm study eligibility and their safety for MRI scanning. Eligible participants will complete informed consent prior to undertaking research MRI scans of their brain, spine, heart, abdomen and parts of their skeleton and muscles. 350 twins with differences in their data will be invited to repeat the MRI scans about two years later to explore longitudinal multi-organ imaging correlates of key environmental exposures based on cross-sectional signals and existing literature.

PROCEDURES Two 45-minute MRI scans of (1) the head and spine and (2) the abdomen to the upper thigh.

OUTCOMES Imaging-derived measures of morphology and function of the brain, spine, abdominal organs and musculoskeletal tissue. These measures will be used to identify twin pair differences related to ageing and disease. A comprehensive repository of MRI data will be created using protocols harmonised with the UK biobank. This will facilitate subsequent linkage with concurrently acquired samples and historic exposome data in longitudinal twin cohort.

Study Type

Observational

Enrollment (Estimated)

2500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • London, United Kingdom, SE1 7EH
        • King's College London

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

TwinsUK Biobank longitudinal registry twin volunteers.

Description

Inclusion Criteria:

  • Identical or non-identical twins
  • Gender: Male or Female
  • Age: 18 years or above at the time of recruitment
  • Must be able to understand the study information and provide informed consent
  • Participation in the TwinsUK Biobank

Exclusion Criteria:

  • Pregnancy
  • Unable to tolerate MRI Procedures, e.g., claustrophobia, severe anxiety
  • Contraindication to MRI Scanning, e.g., presence of non-MR conditional implants
  • Any additional condition declared voluntarily by the participant that the principal investigator (PI) deems likely to affect the study's outcome.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BrainAGE score
Time Frame: At time of scan (duration 45 mins)
BrainAGE will be calculated using MRI-derived phenotypes of brain volumetric changes (Cole et al, 2017).
At time of scan (duration 45 mins)
BodyAGE score
Time Frame: At time of scan (duration 45 mins)
BodyAGE will be calculated using MRI-derived phenotypes of organ and tissue changes in the heart, liver, pancreas, kidneys, spine and muscle (Linge et al, 2018).
At time of scan (duration 45 mins)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Claire Steves, King's College London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 19, 2023

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

March 1, 2028

Study Registration Dates

First Submitted

July 4, 2023

First Submitted That Met QC Criteria

August 23, 2023

First Posted (Actual)

August 28, 2023

Study Record Updates

Last Update Posted (Estimated)

January 25, 2024

Last Update Submitted That Met QC Criteria

January 24, 2024

Last Verified

July 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 322446

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Access to the data may be requested by application to the TwinsUK Resource Executive Committee (TREC).

IPD Sharing Time Frame

The data will be available after the primary analyses have been reported and as determined by TREC based on the application data sharing policies. The data will remain available for the foreseeable future with no end date, at present

IPD Sharing Access Criteria

See the information in the link.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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